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Completed

NCT Number: NCT01320709

Effect of Piroxicam on Ovulation

In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation).

Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals.

With regards to the tolerability of the study drug subjects will be asked regularly how they feel.

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Key information

Conditions

Contraception, Postcoital

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent available before any study specific tests or procedures are performed
  • Healthy female subject
  • Age: 18 to 35 years (inclusive) at the first screening visit
  • Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit
  • Confirmation of the subject's health insurance coverage prior to the first screening visit
  • Willingness to use non-hormonal methods of contraception during the study
  • Ability to understand and follow study-related instructions
  • Adequate venous access

Exclusion criteria

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
  • Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past
  • History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation
  • Regular intake of medication other than hormonal contraceptives
  • Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU)
  • Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure
  • Time point "onset of LH surge" in the pre-treatment cycle not determinable
  • Time point "ovulation" in the pre-treatment cycle not determinable
  • Lacking suitability for frequent TVU examinations
  • History or presence of suffering from hay fever

Treatment and study plan

Piroxicam ( BAYl1902)

Drug

Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)

Placebo

Drug

Single dose of placebo (i.e., 4 placebo capsules)

Primary outcomes

  1. Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge

    Time frame: after 2 months

Secondary outcomes

  1. course of follicle sizes

    Time frame: after 2 months

  2. course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)

    Time frame: after 2 months

  3. Concentration-times courses of piroxicam

    Time frame: after 2 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Single-center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Whether a Single-dose of Either 20 mg Piroxicam, 40 mg Piroxicam or 80 mg Piroxicam Shows an Effect on Ovulation After the Onset of LH Surge Compared to Placebo in Healthy Young Women

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2011
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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